Evaluate the Safety and Efficacy of TJ301

Informed Consent Form for the Phase II, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of TJ301 (FE 999301) Administered Intravenously in Patients with Active Ulcerative Colitis
Introduction
You are being invited to participate in a clinical research study conducted by [Research Institution/Organization Name]. This study aims to evaluate the safety and efficacy of TJ301 (FE 999301) administered intravenously in patients with active ulcerative colitis. Before deciding whether or not to participate, it is important that you understand the purpose, procedures, benefits, and potential risks associated with this study. Please take the time to read this informed consent form carefully. If you have any questions or concerns, feel free to ask the study staff.

Study Purpose
The purpose of this study is to investigate the safety and efficacy of TJ301 (FE 999301) in patients with active ulcerative colitis. The study aims to evaluate the potential benefits of this investigational drug in improving symptoms, reducing disease activity, and enhancing the quality of life for individuals with active ulcerative colitis.

Study Procedures
Screening:

Prior to your participation in this study, you will undergo a screening process to determine if you meet the eligibility criteria. This will involve a review of your medical history, physical examination, laboratory tests, and other assessments as deemed necessary by the study team.
Randomization:

If you meet all the inclusion criteria and none of the exclusion criteria for this study, you will be randomly assigned to receive either TJ301 or a placebo. Randomization means that you will be assigned to a treatment group by chance, similar to flipping a coin.
Treatment Administration:

If assigned to the TJ301 group, you will receive the investigational drug intravenously at specified intervals and doses as determined by the study protocol. If assigned to the placebo group, you will receive an inactive substance that looks like the investigational drug but contains no active ingredients.
Study Visits:

Throughout the study, you will be required to attend regular study visits at the research site. These visits may include physical examinations, laboratory tests, questionnaires, interviews, and other assessments related to your ulcerative colitis symptoms and overall health.
Follow-up:

After completing the study treatment period, there will be a follow-up period during which you may be contacted by the study team for additional assessments or information regarding your health status.
Benefits
Participating in this study may provide both individual and societal benefits. Although there is no guarantee that you will personally benefit from participating in this research, the potential benefits include:

Access to an investigational drug that may improve your ulcerative colitis symptoms and disease activity.
Close monitoring of your condition by experienced healthcare professionals.
Contribution to medical knowledge and advancement in the field of ulcerative colitis treatment.
Risks and Discomforts
As with any clinical study involving investigational drugs, there are potential risks and discomforts associated with participation. These include:

Side effects or adverse reactions to TJ301 or the placebo. These could include but are not limited to nausea, headache, allergic reactions, changes in blood pressure, and gastrointestinal disturbances.
The possibility of receiving a placebo instead of an active drug, which may not have any therapeutic effect on your condition.
Inconvenience and time commitment associated with attending study visits and undergoing various assessments.
The potential for unforeseen risks that are currently unknown due to the investigational nature of TJ301.
Confidentiality
All information collected during this study will be kept strictly confidential. Your identity will be protected throughout the research process. Your personal information will be stored securely and accessible only to authorized research personnel. However, it is important to note that regulatory authorities may have access to your records for monitoring purposes.

Voluntary Participation
Participation in this study is entirely voluntary. You have the right to refuse participation or withdraw from the study at any time without affecting your current or future medical care. Your decision regarding participation will not result in any penalty or loss of benefits.

Compensation
For your time and participation in this study, you may be eligible for compensation as outlined in detail in a separate document provided by the study team. Please ask for clarification if you have any questions regarding compensation.

Contact Information
If you have any questions or concerns about this study or your rights as a participant, please feel free to contact:

[Principal Investigator Name] [Research Institution/Organization Name] [Phone Number] [Email]

By signing below, you confirm that:

You have read and understood the information provided in this informed consent form.
You have had an opportunity to ask questions and all your concerns have been addressed satisfactorily.
You voluntarily agree to participate in this study.
Participant Signature: ______________________ Date: ______________________